CLASS II Device recall · Reported 3 Jun 2015 · FDA Enforcement Report
Keo Brace, elastic wrist brace for carpal tunnel recalled
United Surgical Associates is recalling Keo Brace, elastic wrist brace for carpal tunnel, distributed nationwide in the US. The recall was initiated on 13 Apr 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1666-2015
- FDA event ID
- 71256
- Recalling firm
- United Surgical Associates, Fort Wayne, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Apr 2015
- FDA classified
- 23 May 2015
- Reported
- 3 Jun 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Masks, Gloves & PPE
Timeline
| 13 Apr 2015 | Recall initiated by company | |
| 23 May 2015 | Classified by FDA | +40 days |
| 3 Jun 2015 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Keo Brace, elastic wrist brace for carpal tunnel. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.
Where it was distributed
Domestic: HI International; None
Questions about this recall
Is Keo Brace, elastic wrist brace for carpal tunnel recalled?
Yes. United Surgical Associates recalled Keo Brace, elastic wrist brace for carpal tunnel on 13 Apr 2015. The recall is Class II and its status is Terminated. Recall number Z-1666-2015.
Why was it recalled?
The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction
Which lots are affected?
Product # i-75100 Lot# AK20140801002
Where was it sold?
Domestic: HI International; None
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from United Surgical Associates
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|---|---|---|---|---|---|
| Device | CLASS II | Elastic Knee Support recalled by United Surgical Associates | United Surgical Associates | Device Malfunction | Nationwide |
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